CARE Study: Cancer, Asian Americans, and Relationship Enrichment (CARE)

Positive Activities for Asian American Cancer Patients and Caregivers

The overarching goal of the current study is to reduce the burden Asian American patients may feel are on their caregivers by designing and testing the feasibility and efficacy of a positive activity intervention designed to increase a sense of autonomy, competence, and connectedness, each of which have been shown to be associated with psychological benefits according to self-determination theory.

Study Overview

• Status: Recruiting
• Conditions: Neoplasm
• Intervention / Treatment: Behavioral: Contribution to Caregivers Well-Being; Behavioral: Control

Detailed Description

This study will introduce two new positive activities, household contribution and outside contribution, which have been specifically created for AA cancer patients and have not been previously investigated. These interventions have been developed with consideration of culture-related challenges, Hofstede's concept of collectivist cultures, and self-determination theory. This study will be the first randomized controlled trial to assess the impact of these new positive activities on Asian-American cancer patients.

• Study Type: Interventional
• Enrollment (Estimated): 186
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lilian J. Shin-Cho, PhD; Phone Number: 267-889-2209; Email: Lilian.Shin-Cho@fccc.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Recruiting
      • Fox Chase Cancer Center - Philadelphia
      • Contact: Lilian Shin-Cho, PhD; Phone Number: 2678892209; Email: lilian.shin-cho@fccc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria for Patients:

1. self-identifies as Asian American or Asian
2. males or females ages 21-80 years
3. within 2 years of any cancer diagnosis or stage 4 cancer diagnosis
4. actively undergoing surgery or systemic therapy (e.g., chemotherapy, radiation, immunotherapy) or within the past 6 months,
5. able to identify a caregiver (e.g., spouse) who lives in the same household or see at least 3 times per week
6. able to read, write, and speak English (i.e., English proficient; EP) or Mandarin/simplified Chinese.

Exclusion Criteria for patients:

1. life expectancy less than 6 months in the opinion of the primary physician
2. inability to stand or walk on their own or other physical limitations that preclude them from participating (3+ on ECOG performance status),
3. major thought disorder (e.g., schizophrenia or bipolar [patient records or self-disclosure]).

Inclusion Criteria for Caregivers:

1. identifies as Asian American or Asian,
2. patient considers them to be caregiver
3. English proficient or Mandarin Chinese proficient
4. access to computer/phone, internet, and web browser.

Exclusion Criteria for Caregivers:

1. unwilling or unable to participate in the study for any reason,
2. under the age of 18.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Contribution; Contribution to caregiver wellbeing via household tasks. If the household contribution condition is chosen, participants will be given instructions and examples/list of things they could do to contribute to the well-being of their caregiver (e.g., cook a meal, take pet for a walk, water the plants). If the outside contribution condition is chosen, participants will be given instructions and examples/list of things they could do to contribute to the world outside of their own home (e.g., pick up litter in neighborhood, buy coffee for stranger, donate food/clothing to homeless)	Behavioral: Contribution to Caregivers Well-Being; Contribute to caregiver's well-being via household tasks.; Other Names: Household Contribution; Internal Contribution
Placebo Comparator: Control Group; Participants in the control group will be asked to factually describe either (1) immediate environment, (2) the weather, or (3) organization of closet	Behavioral: Control; factually describe either (1) immediate environment, (2) the weather, or (3) organization of closet; Other Names: Control Group; Experimental Arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Affect-Adjective Scale (modified) (AAS)	Primary Outcome Measure: affective well-being scores range from 0-6, with 6 indicating higher negative or positive affect	Baseline/pre-intervention, midpoint/during the intervention (2 weeks), immediately after the intervention (4 weeks), and follow-up 4 weeks after the intervention (8 weeks)
Patient-Reported Outcomes Measurement Information System Global Health (PROMIS G10)	Primary Outcome Measure: health-related quality of life scores range from 3 to 15, with higher scores indicating better physical health scores range from 4 to 20, with high scores indicating better mental health	Baseline/pre-intervention, midpoint/during the intervention (2 weeks), immediately after the intervention (4 weeks), and follow-up 4 weeks after the intervention (8 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Balanced Measure of Psychological Needs (BMPN)	Secondary Outcome Measure: autonomy, competence, and connectedness scores range from 1 to 5, with higher scores indicating more autonomy, competence, or connectedness	Baseline/pre-intervention, midpoint/during the intervention (2 weeks), immediately after the intervention (4 weeks), and follow-up 4 weeks after the intervention (8 weeks)
Self-Perceived Burden Scale	Secondary Outcome Measure: perceived burdensomeness scores range from 10 to 50, with higher scores indicating more self-perceived burdensomeness	Baseline/pre-intervention, midpoint/during the intervention (2 weeks), immediately after the intervention (4 weeks), and follow-up 4 weeks after the intervention (8 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Stress Scale (PSS)	Other Pre-specified Outcome Measure: patient stres PSS: scores range from 0 to 16, with higher scores indicating more stress	Baseline/pre-intervention, midpoint/during the intervention (2 weeks), immediately after the intervention (4 weeks), and follow-up 4 weeks after the intervention(8 weeks)
PROMIS Patient-Reported Outcomes Measurement Information System Depression 4a (PROMIS Depr4a)	Other Pre-specified Outcome Measure: depression PROMIS Depr4a: scores range from 4 to 20 with higher scores indicating more depressive symptoms	Baseline/pre-intervention, midpoint/during the intervention (2 weeks), immediately after the intervention (4 weeks), and follow-up 4 weeks after the intervention(8 weeks)
MD Anderson Symptom Inventory (MDASI)	Other Pre-specified Outcome Measure: clinical symptoms MDASI: scores range from 0 to 10 with higher scores indicating more symptoms or more interference	Baseline/pre-intervention, midpoint/during the intervention (2 weeks), immediately after the intervention (4 weeks), and follow-up 4 weeks after the intervention(8 weeks)
Getting Along Scale	Other Pre-specified Outcome Measure: interpersonal well-being Getting Along: scores range from 4 to 16, with higher scores indicating getting along better	Baseline/pre-intervention, midpoint/during the intervention (2 weeks), immediately after the intervention (4 weeks), and follow-up 4 weeks after the intervention(8 weeks)

Collaborators and Investigators

• Sponsor: Fox Chase Cancer Center
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2024
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): February 15, 2027

Study Registration Dates

• First Submitted: September 6, 2024
• First Submitted That Met QC Criteria: January 16, 2025
• First Posted (Actual): January 20, 2025

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Cancer; Patient; Caregiver; Well-being; Asian American; Positive Activities
• Additional Relevant MeSH Terms: Neoplasms; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: 24-1006; 5R00CA267678-04 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No